Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck
|ClinicalTrials.gov Identifier: NCT01344772|
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : November 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neck Fracture||Procedure: Internal fixation Procedure: Total hip arthroplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck. A Randomized, Controlled Trial With a Seventeen Year Follow-up|
|Study Start Date :||February 1990|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2011|
Active Comparator: Internal fixation
Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.
Procedure: Internal fixation
Two cannulated screws are placed under x-ray guidance
Active Comparator: Total hip replacement
Displaced femoral neck fracture treated with total hip replacement through a posterior approach.
Procedure: Total hip arthroplasty
A total hip arthroplasty is performed through a standard posterior approach
- Harris hip score [ Time Frame: 17 years ]HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function.
- Reoperations and complications [ Time Frame: 17 years ]
IF group: nonunion, osteonecrosis, deep infection or fracture in the vicinity of the screws. Protruding screws or extraction of the screws when the fracture was healed was not defined as a complication.
THR group: radiographic signs of loosening of the femoral- or acetabular component, dislocation, periprosthetic fracture or deep infection
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344772
|Stockholm, Sweden, 182 88|
|Principal Investigator:||Olof Sköldenberg, MD, PhD||Danderyd Hospital|